Alfuzosin for Treating Acute Urinary Retention
- Registration Number
- NCT00336921
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective of the study is to assess the efficacy of alfuzosin 10mg daily in the return to successful voiding after removal of the catheter following a first episode of acute urinary retention (AUR) in patients suffering from benign prostatic hyperplasia (BPH).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 156
Inclusion Criteria
- First episode of painful AUR related to BPH requiring catheterization
- Residual volume between 500ml and 1500ml obtained at the time of catheterization and during the first one hour after catheterization
Exclusion Criteria
- Participated in another investigational study within 3 months before recruitment
- Suspect bladder neuro-dysfunction unrelated to etiology;
- Single Bladder neck disease;
- Acute/chronic prostatitis;
- Diagnosed prostate carcinoma;
- Suspected prostate carcinoma diagnosed by ultrasound wave;
- Surgical history of prostate and urethra;
- Diagnosed/suspected abnormality in urethra structure;
- Bladder stone;
- Blood urine retention caused by any reason;
- Residual volume less than 500 ml
- Residual volume more than 1500 ml
- AUR not due to BPH
- Parkinson's disease
- Insulin dependent diabetes
- Known/suspected multiple sclerosis;
- Stroke/MI within 6 months prior to enrolment;
- AST, ALT and Creatinine > 1.5x upper limit; neutrophil < 3,000/mm³; platelet < 100,000/mm³;
- Unstable/severe heart failure;
- History of postural hypertension/hypotension;
- Known hypersensitivity to α-receptor blocker;
- Suspected/diagnosed expansible nerval disease;
- Treatment with sympathomimetic agent within 1 week prior to enrolment, except OTC drug for cold intermittently;
- Treatment with α1-receptor blocker within 1 month prior to enrolment;
- Treatment with tricyclic antidepressants, anticholinergic agents, sympathomimetic agent (other than the above reason), first generation antihistaminic, except the treatment with stable β sympathomimetic agent/ anticholinergic agents lasting more than 1 week for Asthma and COPD (Chronic Obstructive Pulmonary Disease);
- Treatment with Disopyramide
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Alfuzosin Alfuzosin 10mg 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method Percentage of patients with successful voiding after catheter removal Day 3 and 4 Adverse events From the beginning to the end of the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-aventis
🇨🇳Beijing, China